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FAmily Engagement Strategy for Coordinated Specialty Care

Integration of a Culturally Responsive Family Peer Delivered Engagement Strategy in Coordinated Specialty Care

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06945055
Acronym
FAMES
Enrollment
900
Registered
2025-04-25
Start date
2025-03-01
Completion date
2029-12-01
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family Members, Implementation

Keywords

early psychosis, family peer, engagement

Brief summary

Family members/support persons' engagement in mental health services has been linked to reduced burden and stress and improves engagement and outcomes in individuals in the early stages of psychosis. The goal of FAMES is to address low family member/support person engagement in services. FAMES will also address disparities in coordinated specialty care (CSC) by using a culturally responsive family engagement strategy to be delivered by family peers.

Detailed description

The overall goal of this mixed-methods, clustered stepped-wedged designed study is to examine the effectiveness of a family peer implemented in coordinated specialty care programs at engaging family members in services. The use of a family peer is anticipated to increase family member participant's feelings of connectedness, self-efficacy, and motivation which will in turn improve family member participants engagement in scheduled coordinated specialty care services such as family psychoeducation. Recruitment will consist of dyads compromised of a family member support person and a corresponding individual receiving coordinated specialty care services. Recruitment will occur over two waves, the attention control condition (ACC) and the FAMES condition. The ACC will last for 18 months and will recruit 225 participant dyads during which time family member participants will be contacted weekly for 12 weeks where they will be provided with positively framed messaging, educational materials around psychosis, tips for addressing relevant concerns in areas such as communication and de-escalation, and a list of community-based and online resources and events. The FAMES condition will last for 30 months and will recruit 225 participant dyads during which time family member participants will receive a modified cultural formulation interview, brief check-ins, psychoeducation, and will have access to an online community. Recruitment will take place at nine coordinated specialty care programs across four states (Washington, Oregon, Tennessee, and New Mexico) which have been randomized to a clustered stepped wedge program design.

Interventions

BEHAVIORALFAMES

225 dyads (family member/support persons and individuals receiving services for psychosis) will be recruited over a period of 30 months. Family member/support persons will be connected to a family peer for a period of 12 weeks who will use the cultural formulated interview to develop rapport and identify unique cultural needs which can inform treatment and resource identification. Participants will receive brief contact, family psychoeducation, and be connected to an online family resource group where they can receive additional support from certified peers and other family member/support persons.

BEHAVIORALControl

participants will receive 12 weeks of automated communication which contain positive messaging, appointment reminders, links to community resources, and coping skills.

Sponsors

Washington State University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

A cluster randomized stepped wedge design with an attention control condition (n=225 dyads) lasting 18 months and an active implementation condition (n=225 dyads) lasting 30 months.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Family Member / Support Person Inclusion Criteria: * Family member/support person of an individual enrolled in coordinated specialty care services for less than or equal to 6 months. * 18 years of age or older. * During the active implementation period (FAMES) did not participate in the attention control condition.

Exclusion criteria

* If they do not understand the consent process. * If they do not speak and/or understand English or Spanish. Primary Service User Inclusion Criteria * enrolled in coordinated specialty care services for less than or equal to 6 months. * 15 years of age or older. * Has a family member/support person willing to engage in the study. during the active implementation period (FAMES) did not participate in the attention control condition.

Design outcomes

Primary

MeasureTime frameDescription
Engagement in Family Engagement StrategyBaseline through study completion; repeated measure to assess change through study completion, average of 3 monthsTotal number of Family Engagement Strategy session attended and the total number of contact minutes to measure engagement.
Engagement in coordinated specialty care psychoeducationBaseline through study completion; repeated measure to assess change through study completion, average of 3 monthsWill be measured as first session attendance rate and total attendance rate per family provided by administrative data from the coordinated specialty care site partners.

Secondary

MeasureTime frameDescription
General Anxiety Disorder - 7Baseline through study completion; repeated measure to assess change through study completion, average of 6 monthsSelf-report measure to assess symptoms of anxiety. Scores range from 0-21 where scores greater than 10 are indicative of clinically significant anxiety.
Client - Patient Health Questionnaire - 9Baseline through study completion; repeated measure to assess change through study completion, average of 6 monthsA self-report from the individual receiving coordinated specialty care services on their symptoms of depression. Scores range from 0-27 where any score 10 or greater is indicative of clinically significant symptoms of depression.
Family - Patient Health Questionnaire - 9Baseline through study completion; repeated measure to assess change through study completion, average of 6 monthsA self-report from the family member participant on their symptoms of depression. Scores range from 0-27 where any score 10 or greater is indicative of clinically significant symptoms of depression.
Client EngagementBaseline through study completion; repeated measure to assess change through study completion, average of 6 monthsProvider reported service utilization. Total number of appointments attended.
Community Assessment of Psychic Experiences - Positive Scale 15-items ScaleBaseline through study completion; repeated measure to assess change through study completion, average of 6 monthsA self-report measure from the individual receiving the coordinated specialty care services. Scores range from 0-3 where scores greater than 1.46 indicate clinically significant symptoms of psychosis.
Perceived Stress ScaleBaseline through study completion; repeated measure to assess change through study completion, average of 6 monthsA self-report measure which includes 10 Likert-style items to assess the degree to which an individual appraises life as stressful. Scores range from 0-40 where scores greater that 13 indicate moderate to high perceived stress.

Countries

United States

Contacts

CONTACTOladunni Oluwoye, Associate Professor, Ph.D.
oladunni.oluwoye@wsu.edu509-368-6805
CONTACTBryony Stokes, Program Manager, M.S.
bryony.mueller@wsu.edu509-505-7001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026